1. Field of Invention
The invention relates generally to medical devices and more particularly to a low profile device including respective gastrostomy and jejunostomy lumens allowing both gastric and jejunal access. The invention further relates to compositions for coating such devices to prevent or treat granulomas.
2. Description of Related Art
There are many patients who are unable to orally receive nutrition due to physical or physiologic conditions caused by diseases or other maladies. People suffering from stroke, Alzheimer's disease, cancer, inflammation, or other infirmities, often cannot properly chew, swallow or absorb their food or medication, which must then be delivered to the patient in another fashion if starvation and malnutrition are to be avoided.
Gastrostomy/jejunostomy tubes have become the method of choice in providing long-term nutritional support to children and adults. Gastrostomy/jejunostomy tubes may either be placed through the surgical creation of an ostomy while the patient is under general anesthesia or by means of percutaneous endoscopic gastrostomy (PEG) or by percutaneously radiographically placed gastrostomy, which involves a non-invasive creation of an opening or stoma in the stomach through the abdominal wall.
There are often instances in which it is preferable to introduce the patient's nutritional requirements in the form of a liquid formula to the jejunum portion of the small intestine rather than the stomach. Some patients for example, when fed directly to the stomach, encounter a problem with such delivery known as reflux. In reflux, digested gastric residue is vomited up out the stomach and into the esophagus. Chronically ill or bed-ridden patients who are unable to swallow normally may inadvertently inhale the gastric reflux into the lungs resulting in asphyxiation or pneumonia. The tube itself can be forced out of the stomach as well. These situations in particular call for jejunal delivery of the nutritional formula.
It has been found in these instances that more efficacious feeding can be achieved if the feeding tube is passed through the pyloric area, and formula is passed directly into the patient's small intestine via a jejunostomy tube, rather than the patient's stomach. It has been further noted that when the feeding tube is installed so that the distal end is past the patient's pyloric valve, the tendency for the tube to be refluxed up to the esophagus is significantly reduced.
The jejunal feeding tube (a J-tube) is introduced either through a surgically created ostomy or through the nasopharyngeal passageway. A J-tube can also be placed directly through the stomach (gastrostomy), passing through the pyloris directly into the midsection of the small bowels (jejunal).
The combination of a gastrostomy and jejunostomy tube has been used for transpyloric feeding with the ability to vent the stomach. Various patents disclose gastrostomy device and/or jejunostomy devices. See for example, U.S. Pat. No.: 6,328,720 (McNally et al.); U.S. Pat. No. 5,871,467 (Reuning et al.); U.S. Pat. No. 5,549,657 (Stern, et al.); U.S. Pat. No. 5,411,491 (Goldhardt, et al.); U.S. Pat. No. 5,391,159 (Hirsch, et al.); U.S. Pat. No. 5,356,391 (Stewart); U.S. Pat. No. 5,342,321 (Potter); U.S. Pat. No. 5,336,203 (Goldhardt, et al.); U.S. Pat. No. 5,080,650 (Hirsch, et al.); U.S. Pat. No. 4,861,334 (Nawaz); U.S. Pat. No. 4,850,953 (Haber, et al.), and U.S. Pat. No. 3,915,171 (Shermata).
Typical conventional gastrostomy and jejunostomy devices commercially available today extend about 6 to 8 inches from the patient's torso and are heavy. Their relatively large size and weight renders them less than optimal insofar as comfort and concealability is concerned. Moreover, such large and heavy devices are particularly unsuitable for pediatric usage. Low profile gastrostomy and jejunostomy devices are disclosed in U.S. Pat. No.: 6,287,281 (Nishtala); U.S. Pat. No. 6,045,536 (Meier et al.) and U.S. Pat. No. 4,863,436 (Gauderer et al.) and U.S. Design Letters Patent No. D350,393 (Potter) and one such device is commercially available from Kimberly-Clark Corp (Dallas, Tex.) under the trade designation KIMBERLY-CLARK MIC Transgastric-Jejunal Feeding Tubes. That device basically comprises a tube for jejunal feeding with multiple feeding exit ports, a jejunal feeding port, a tube for gastric decompression with multiple gastric ports, a gastric decompression port, and an inflatable internal retention balloon. The jejunal feeding port and the gastric decompression port are made at the respective angles of approximately 90° and 45°. Disadvantages of this device include uneven flow and possible clogging due to its geometry.
Another disadvantage of prior art gastrostomy and jejunostomy devices is their tendency to produce undesirable granuloma tissue at the stoma site, particularly under long-term use conditions.
Thus, it is desirable to provide an improved gastrostomy/jejunostomy device that is capable of allowing both gastric access and jejunal access, which is light weight, has a low external profile, prevents or lessens the formation of granulomas at the stoma, and is capable of use in pediatric medicine.
All references cited herein are incorporated herein by reference in their entireties.